Summary: The Data Quality Analyst intern will assist with regulatory compliance, risk management, and integral management system implementation within clinical technology. Highlights: 1. Ideal for students interested in quality systems and regulatory frameworks. 2. Responsibilities include drafting documents and performing risk assessments. 3. Supports GAMP 5 and 21 CRF Part 11 alignment. **Job Overview:** The Data Quality Analyst intern will assist with regulatory compliance, risk management, and the implementation of the integral management system within clinical technology systems. Responsibilities include drafting and maintaining controlled documents, contacting and following up with main stakeholders, supporting GAMP 5 and 21 CRF Part 11 alignment, performing FMEA and other risk assessments, and ensuring audit\-ready quality records. This position is ideal for students interested in quality systems, regulatory frameworks, integral management system implementation, and good practices compliance within technology. **Summary of Responsibilities:** * Assist in writing and revising controlled documents (SOP, WI, and validation documentation). * Conduct FMEA for key processes within the Clinical Technical Configuration Team (EDC/CTMS/iGPS integration Set\-Up and updates; team members assignments…). * Map controls to 21 CFR Part 11 (Audit trails, security, e\-records/signatures) and GAMP 5 categories. * Coordinate document lifecycle (versioning, approvals, periodic review). **Qualifications (Minimum Required):** * Strong writing and structure (English language) – no AI or reduced use of AI. * Understanding basics of risk management (severity/occurrence/detection). * Ability to read and apply regulatory compliance (English 85%). **Experience (Minimum Required):** * No clinical experience required **Physical Demands / Work Environment:** * Home Based Position. * Minimum Office attendance required. * General office environment. Learn more about our EEO \& Accommodations request here.